| qms_version | 2.2.0 |
|---|---|
| sop_version | 2.0.4 |
| Document ID | CSC PR.011 |
| Document Version | 2.0.4 |
| Author | |
| Approval | |
| QMS Version | 2.2.0 |
| Regulatory References | ISO 13485:2016 Section 5.6 |
The purpose of this SOP is to ensure ongoing adequacy, suitability and efficacy of the QMS and organizational processes.
The CSC Team regularly conducts a management review to document the assessment of QMS surveillance outputs and overall compliance with regulatory requirements. These reviews involve the analysis of all measures involved in the performance of the QMS and the effectiveness of any corrective and preventative measures taken.
| Acronym | Definition |
|---|---|
| CSC | Clinical Scientific Computing |
| QMS | Quality Management System |
| QMO | Quality Management Officer |
| KPI | Key Performance Indicators |
| CAPA | Corrective and Preventive Actions |
At the start of the project the following roles must be allocated. The persons filling each role must have adequate training to fulfil the responsibilities associated.
| Role | Responsibility |
|---|---|
| Head of Medical Physics | Calls the review meeting at a specified interval (see CSC I.004 Schedules) or when dictated by exceptional circumstances |
| CSC QMO | Quality management officer supports the management review |
| Quality Manager for Medical physics | Minutes the meeting and reports findings from the performance analysis |
| CSC Quality Representatives | Attends meeting and assists with the performance analysis report |
The CSC Team use various KPIs to measure the performance of different processes. For the purposes of the management review, the following data must be collected:
- Status of Measures of Previous Management Reviews
Input: which previous measures have been implemented as planned.
Management will evaluate the effectiveness and efficacy of previous measures, and any follow-up actions. - Audits Results
Input: findings and measures from internal audits, audits by external authorities and/or notified bodies. - Quality Policy and Quality Objectives
Input: the quality policy and quality objectives defined in the quality manual. - Status of CAPA
Input: summary of non-conformities found and respective actions taken. - Status of feedback management and complaint handling
Input: summary of feedback and complaints received and actions taken in response. - Status of risk management
Input: summary of actions taken as part of risk management, e.g. risk mitigation, updates of the risk management report, results from post-deployment and observation in clinical use, etc. - Status of incident reporting
Input: potential incidents that were assessed, incidents that were reported, summary of coordination with supervisory authorities, actions taken as result. - Status of applicable regulations and standards
Input: published and/or anticipated updates of applicable regulations and standards, including expected implications for the QMS. - Changes to the QMS
Input: implemented and/or anticipated changes, including those as a result of CAPAs with a significant change,
that impact the QMS (and which, ideally, are assessed as part of the change evaluation list -
for instance, changes to the organizational structure, infrastructure, processes, or clinical requirements). Input: CAPAs where a significant change was identified, assess that notified body has been contacted about the change and
regulatory requirements have been fulfilled. - Authorisation Log Input:Review auth log for completeness and if team has appropriate skill mix to complete with work and quality objectives.
- Opportunities for Improvement/ Input: Any opportunities to further improvement should be analysed.
- Monitoring and Measurement/ Input: overview of monitoring and measurement activities conducted across relevant processes and summary of outcomes.
- Resources/
Input: assessment of current resource adequacy, including staffing levels, training and availability of hardware/infrastructure.
- Customer Feedback/ Input: summary of customer satisfaction data and feedback received through different channels, with reference to any trends or significant issues.
- Other KPIs
While not every process of the QMS requires a KPI, most processes should be assigned an indicator that allows the assessment of process effectiveness, unless there is a valid explanation for why no KPI is reasonably applicable.
The management review report will provide an assessment of the adequacy, suitability, and efficacy of the QMS to comply with regulatory requirements. The inputs of the performance analysis report will be reviewed, and any comments/actions will be logged. Additionally, process impact on product safety will be critically reviewed, along with any improvements on individual products relating to customer requirements.
As part of this process, the management will also review the CSC Teams quality policy, quality objectives and the status of previous strategic goals. It defines new strategic goals for the next review period.
Based on findings during the management review, the management may define further measures such as the revision of single processes, product changes or the (re-)allocation of resources.
A management review will be conducted once per year, or as specified by the Head of Medical Physics for exceptional circumstances.
At the beginning of every review period, management together with the QMO defines KPIs for QMS processes and strategic goals for the team. The strategic goals are based on the organisation’s quality objectives as defined in the quality manual. The results of this process are communicated to all relevant members of the organisation.
| Participants | Management, QMO |
| Input | Quality Policy, Quality Objectives |
| Output | Strategic Goals, Process KPIs |
Every process owner is responsible for tracking the KPI of their process during the review period and to maintain records as required by the process.
Trend analysis may be used to analyse data. Data collected from trend analysis includes statistics for CAPA close out times, staff and quality reps assigned to CAPAs, non-conformance types from internal audits (e.g. process interaction, training, doc and record controls) and user complaint trends.
At the end of a review period, the QMO collects data input from process owners and trend analysis, and analyses the KPI data against pre-defined criteria in preparation for the management review. The QMO may undertake further investigation to identify non-conformities and to provide a preliminary assessment of the adequacy, suitability and efficacy of the QMS.
All Q-Pulse documents referenced by this QMS are reviewed for effectiveness as per CSC PR.022 "Control of QPULSE Documents".
| Participants | QMO, Process Owners |
| Input | KPI records |
| Output | Completed data analysis |
Management and QMO together discuss the reported input and completed data analysis. Management is responsible for evaluation of the results against the pre-defined criteria and must formulate an assessment of the adequacy, suitability, and efficacy of the QMS. Where necessary, the management defines measures for improvement. The results of the management review are documented in the management review report.
Finally, the management sets strategic goals and, where necessary, new or revised process KPIs for the next review period. This is communicated to all relevant members of the team.
| Participants | Management, QMO |
| Input | Completed data analysis |
| Output | Management review report, new or revised KPIs and strategic goals, planned measures |
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